scholarly journals Safety and side effect profile of Pfizer-BioNTech COVID-19 vaccination among healthcare workers: A tertiary hospital experience in Singapore

2021 ◽  
Vol 50 (9) ◽  
pp. 703-711
Author(s):  
See Ming Lim ◽  
Hwang Ching Chan ◽  
Amelia Santosa ◽  
Swee Chye Quek ◽  
Eugene Hern Choon Liu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Adverse Events ◽  
Injection Site ◽  
Side Effect ◽  
Healthcare Workers ◽  
Tertiary Hospital ◽  
University Hospital ◽  
Health Clinic ◽  
Common Symptom

ABSTRACT Introduction: Vaccination remains a key strategy to living endemically with COVID-19. The Pfizer-BioNTech COVID-19 vaccine was first granted interim authorisation for use in Singapore in December 2020. With overseas studies published about the safety and side effect profiles of mRNA COVID-19 vaccines focusing mainly on non-Asian populations, we described the side effects of Pfizer-BioNTech COVID-19 vaccination experienced by the healthcare workers (HCWs) in a tertiary hospital in Singapore. Methods: Data were obtained from the Occupational Health Clinic (OHC) at the National University Hospital in Singapore, which monitored staff for any adverse effects within 30 minutes postvaccination on-site and any adverse effects after that. A cross-sectional study among the vaccinated HCWs was conducted using an online survey, which established basic demographics, histories of allergies or atopic disorders, and adverse events encountered after dose 1 and dose 2 of vaccination. Results: No anaphylaxis was reported. Most common symptom was giddiness (32.7%) experienced by HCWs within 30 minutes. Adverse events attended post-vaccination by OHC were generally mild and self-limiting. From the survey, odds of experiencing an adverse event after dose 2 was significantly higher than after the first dose, especially for fever/chills (odds ratio [OR] 22.5). Fever/chills, injection site reactions, headache, aches and pains, and feeling unwell were significantly more common in HCWs below 60 years compared to those ≥60 years. An allergy to food (adjusted OR 2.7) and a history of eczema/sensitive skin (adjusted OR 2.6) were associated with a skin reaction not at injection site. Conclusion: The side effects experienced after Pfizer-BioNTech COVID-19 vaccines are generally self-limiting and mild, with no anaphylaxis reported. Keywords: COVID-19, infectious diseases, occupational medicine, side effects, vaccination

scholarly journals Neutralizing Antibodies Titers and Side Effects in Response to BNT162b2 Vaccine in Healthcare Workers with and without Prior SARS-CoV-2 Infection

Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 742
Author(s):  
José Javier Morales-Núñez ◽  
José Francisco Muñoz-Valle ◽  
Carlos Meza-López ◽  
Lin-Fa Wang ◽  
Andrea Carolina Machado Sulbarán ◽  
...  
Keyword(s):  
Single Dose ◽  
Side Effects ◽  
Adverse Effects ◽  
Antibody Production ◽  
Neutralizing Antibodies ◽  
Healthcare Workers ◽  
Vaccination Program ◽  
Expected Result ◽  
Neutralizing Capacity ◽  
The Usa

The main expected result of a vaccine against viruses is the ability to produce neutralizing antibodies. Currently, several vaccines against SARS-CoV-2 are being applied to prevent mortal complications, being Pfizer-BioNTech (BNT162b2) one of the first to be authorized in the USA and Mexico (11 December 2020). This study evaluated the efficacy of this vaccine on antibody production with neutralizing capacity and its side effects in healthcare workers with and without prior SARS-CoV-2 infection and in a group of unvaccinated individuals with prior COVID-19. The main findings are the production of 100% neutralizing antibodies in both groups after the second dose, well-tolerated adverse effects, the possible presence of immunosenescence, and finally, we support that a single dose of this vaccine in individuals with prior COVID-19 would be sufficient to achieve an immunization comparable to people without prior COVID-19 with a complete vaccination program (2 doses).

Short-term adverse effects of testosterone used for priming in prepubertal boys before growth hormone stimulation test

2018 ◽  
Vol 31 (1) ◽  
pp. 21-24 ◽  
Author(s):  
Andrea Albrecht ◽  
Theresa Penger ◽  
Michaela Marx ◽  
Karin Hirsch ◽  
Helmuth G. Dörr
Keyword(s):  
Growth Hormone ◽  
Side Effects ◽  
Adverse Effects ◽  
Side Effect ◽  
Serum Testosterone ◽  
Low Flow ◽  
Effect Rate ◽  
Testosterone Levels ◽  
Testicular Pain ◽  
Prepubertal Boys

AbstractBackground:Despite the fact that priming with sex steroids in prepubertal children before growth hormone (GH) provocative tests is recommended, there is an ongoing controversial discussion about the appropriate age of the children, the drug used for priming, the dose and the period between priming and the GH test. Interestingly, there is no discussion on the safety of this procedure. To date, only little data have been available on the possible side effects of priming with testosterone.Methods:We analyzed the outcome in 188 short-statured prepubertal boys who had been primed with testosterone enanthate (n=136: 50 mg; n=51: 125 mg, and accidentally one boy with 250 mg) 7 days prior to the GH test. Serum testosterone levels were measured on the day of the GH test in 99 boys.Results:Overall, only five boys developed adverse side effects. Two boys (dose 125 mg) showed severe low-flow priapism and had to undergo decompression of the corpora cavernosa. One boy suffered from self-limiting priapism and testicular pain (dose 50 mg). Two patients reported testicular pain (each dose 50 mg). The single patient with 250 mg testosterone did not show any adverse effects. The total side effect rate was 2.7%. The serum testosterone levels of the boys with side effects were not different from the testosterone levels of the boys without any side effects.Conclusions:Parents and patients should be informed about the possible side effects of priming with testosterone such as priapism and testicular pain. However, the overall side effect rate is low. We found no correlation between the outcome and the testosterone dose used and/or the level of serum testosterone.

Elucidating the Potential Side Effects of Current Anti- Seizure Drugs for Epilepsy

2021 ◽  
Vol 19 ◽  
Author(s):  
Enes Akyüz ◽  
Mohd. Farooq Shaikh ◽  
Betül Köklü ◽  
Cansu Ozenen ◽  
Alina Arulsamy
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Effects ◽  
Side Effect ◽  
First Line ◽  
Epileptic Patients ◽  
Life Threatening ◽  
Visual Problems ◽  
Gaba Transmission

: Over the decades, various interventions have been developed and utilized to treat epilepsy. However, majority of epileptic patients are often first prescribed with anti-epileptic drugs (AED), now known as anti-seizure drugs (ASD), as a first line of defense to suppress their seizures and regain their quality of life. ASDs exert their anti-convulsant effects through various mechanisms of action including regulation of ion channels, blocking of glutamate-mediated stimulating neurotransmitter interaction, and enhancing the inhibitory GABA transmission. About one third of epileptic patients are often resistant to anti-convulsant drugs, while others develop numerous side effects which may lead to treatment discontinuation and further deterioration of quality of life. Common side effects of ASDs include headache, nausea and dizziness. However, more adverse effects such as auditory and visual problems, skin problems, liver dysfunction, pancreatitis and kidney disorders may also be witnessed. Some ASDs may even result in life-threatening conditions as well as serious abnormalities, especially in patients with comorbidities and in pregnant women. Nevertheless, some clinicians had observed a reduction in the development of side effects post individualized ASD treatment. This suggest that a careful and well-informed ASD recommendation to patients may be crucial for an effective and side-effect free control of their seizures. Therefore, this review aimed to elucidate the anticonvulsant effects of ASDs as well as their side effect profile, by discussing their mechanism of action and reported adverse effects based on clinical and preclinical studies, thereby providing clinicians with a greater understanding of the safety of current ASDs.

scholarly journals Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia

2021 ◽  
Vol 14 (9) ◽  
pp. 873
Author(s):  
Abanoub Riad ◽  
Barbora Hocková ◽  
Lucia Kantorová ◽  
Rastislav Slávik ◽  
Lucia Spurná ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Healthcare Workers ◽  
Large Scale ◽  
Large Population ◽  
Medical Attention ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Post Vaccination ◽  
Phase Iv

mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants’ demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.

Ophthalmic adverse effects of immune checkpoint inhibitors: the Mayo Clinic experience

2020 ◽  
pp. bjophthalmol-2020-316970 ◽  
Author(s):  
Blake Hugo Fortes ◽  
Harris Liou ◽  
Lauren A Dalvin
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Immune Checkpoint ◽  
Ocular Surface ◽  
Side Effect ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitor ◽  
Checkpoint Inhibitors ◽  
Common Side Effect ◽  
Targeting Therapy

Background/AimsTo investigate immune-related ophthalmic side effects of systemic checkpoint inhibitors and compare side effect frequency and requirement for cessation of immunotherapy by checkpoint target.MethodsPatients taking immune checkpoint inhibitors at a single centre from January 1, 2010 to February 29, 2020 were retrospectively reviewed for clinical characteristics, treatments and concurrent systemic adverse effects.ResultsOf 996 patients, 28 (2.8%) experienced an ophthalmic side effect that came to the attention of an eye care provider. Mean age at presentation of the side effect was 63 years (median 64, range 25–88). The checkpoint inhibitor most often preceding side effects was pembrolizumab in 12 (43%). The most common side effect was dry eye in 16 (57%), followed by uveitis in 4 (14%) patients, and singular cases of ptosis and binocular diplopia, among others. Ocular surface adverse effects occurred more frequently with programmed death ligand-1 (PD-L1) targeting therapy. There were no significant differences in the frequency of orbit/ocular adnexa and uveitis or retinal side effects based on checkpoint targets. Follow-up was available in 13 (46%) patients, with mean duration of 20 months (median 16, range 2–52 months). Of these patients, the ophthalmic side effects were controlled without discontinuing therapy in 12 (92%). Checkpoint inhibitor cessation was required in one patient with panuveitis.ConclusionOphthalmic immune-related adverse events are rare but could be more common than previously estimated. PD-L1-directed checkpoint inhibitors may have a slight predilection for ocular surface adverse effects. Most ophthalmic events can be treated with targeted therapy without discontinuation of life-prolonging immunotherapy.

scholarly journals Impact of Pharmacist Counselling on Clozapine Knowledge

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Ciara Ní Dhubhlaing ◽  
Ailish Young ◽  
Laura J. Sahm
Keyword(s):  
Side Effects ◽  
Patient Information ◽  
Side Effect ◽  
Information Sources ◽  
Knowledge Score ◽  
University Hospital ◽  
Patient Knowledge ◽  
Specific Knowledge ◽  
The Impact ◽  
Improve Patient

Clozapine is the only antipsychotic with evidence for efficacy in treatment of resistant schizophrenia but it carries a high side effect burden. Patient information is provided but may be poorly retained. This study aims to examine the impact of pharmacist counselling upon patient knowledge of clozapine. Outpatients, aged 18 years and over, attending St. Patrick’s University Hospital, Dublin, participated in this study between June and August 2015. The intervention consisted of pharmacist counselling on two occasions one month apart. Knowledge was assessed using a 28-point checklist devised from the currently available clozapine patient information sources, at baseline and after each counselling session. Ethics approval was obtained. Twenty-five participants (40% female; mean age 45.1 years, SD 9.82; 64% unemployed, 28% smokers) showed an improvement in knowledge scores of clozapine from baseline to postcounselling on each occasion with an overall improvement in knowledge score, from baseline to postcounselling at one month, of 39.43%; p<0.001. This study adds to the evidence that interventions involving pharmacist counselling can improve patient knowledge, whilst the specific knowledge gained relating to recognition of side effects may help patients towards more empowerment regarding their treatment.

Effects of the dopamine agonist cabergoline in patients with prolactinoma intolerant or resistant to bromocriptine

1996 ◽  
Vol 134 (4) ◽  
pp. 454-456 ◽  
Author(s):  
Etienne Delgrange ◽  
Dominique Maiter ◽  
Julian Donckier
Keyword(s):  
Internal Medicine ◽  
Side Effects ◽  
Dopamine Agonist ◽  
Side Effect ◽  
University Hospital ◽  
The Third ◽  
Group I ◽  
Resistant Group ◽  
Group Ii ◽  
Long Acting

Delgrange E, Maiter D, Donckier J. Effects of the dopamine agonist cabergoline in patients with prolactinoma intolerant or resistant to bromocriptine. Eur J Endocrinol 1996;134:454–6. ISSN 0804–4643 Cabergoline is a new long-acting ergoline derivative used to treat hyperprolactinaemia. Its effect was assessed in 10 patients (eight women and two men) with prolactinoma who were intolerant (group I; N = 7) or resistant (group II; N = 3) to bromocriptine. In group I, no side effect was observed on cabergoline therapy; two patients became pregnant and normoprolactinaemia was achieved in the five others. In group II, cabergoline was active and well-tolerated in two out of the three patients: one woman had three consecutive pregnancies; in another patient normoprolactinaemia was restored and the tumour shrank by 60%; in the third patient cabergoline was discontinued because of side effects and inefficacy. Thus, cabergoline appears to be an alternative of choice as treatment of hyper-prolactinaemic patients who are intolerant or resistant to bromocriptine. Julian Donckier, Internal Medicine and Endocrinology, University Hospital UCL of Mont-Godinne, B-5530 Yvoir, Belgium

scholarly journals Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

2020 ◽  
Author(s):  
Nigel Kirby ◽  
Victoria Shepherd ◽  
Jeremy Howick ◽  
Sophie Betteridge ◽  
Kerenza Hood
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Adverse Events ◽  
Medicinal Products ◽  
Flesch Reading Ease ◽  
Information Leaflets ◽  
Potential Benefits ◽  
Nocebo Effects ◽  
Trial Participants ◽  
Participant Information

Abstract Background Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). However, little is known about how information on potential side effects is provided to trial participants. In this study we aimed to increase the evidence-base in this area by identifying the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry. Eligible studies were placebo controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK in three targeted clinical areas (cancer, musculoskeletal conditions and mental and behavioural disorders). Ongoing and recently completed (within three years) trials were included. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results PILs from 33 studies were included. Most of the patient information leaflets were ranked as ‘fairly easy to read’ or ‘difficult to read’ according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33 64%). Discussion Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. In comparison to the adverse effects, potential benefits from the intervention and/or study were described less often and by shorter text. Participants were commonly presented with adverse effects ahead of any potential benefits.

scholarly journals Pfizer-BioNTech vaccine side effects among healthcare workers in Malta

2021 ◽  
Vol 31 (Supplement_3) ◽  
Author(s):  
S Cuschieri ◽  
M Borg ◽  
S Agius ◽  
J Souness ◽  
A Brincat ◽  
...  
Keyword(s):  
Side Effects ◽  
Injection Site ◽  
Healthcare Workers ◽  
Response Rate ◽  
Demographic Data ◽  
Regression Analyses ◽  
Eligible Population ◽  
Serious Infection ◽  
E Mail ◽  
Roll Out

Abstract Background COVID-19 vaccination is critical to protect healthcare workers (HCWs) from serious infection. The first vaccine approved for emergency use was the Pfizer-BioNtech vaccine. European countries received their first supplies at the end of December 2020. The European country of Malta started its vaccination roll-out immediately targeting HCWs. The aim of this study was to evaluate side effects. Methods An anonymous online Google Forms survey was disseminated to all HCWs via work e-mail addresses (29th March to 9th April 2021). This gathered demographic data and side-effects regarding pain, redness, and swelling at the injection site, fever, chills, fatigue, muscle/joint pains, headache, vomiting, and diarrhea severity following each dose (Likert scale). Descriptive, comparative, and multiple binary regression analyses were performed. Results There were 1480 responses (response rate 30.30%). The commonest side-effect (SE) was pain at the injection site (88.92% CI95%:87.21-90.42), with the majority reporting it as mild (51%) and moderate (43%). Fatigue reported by 72.97% (CI95%:70.65-75.17), with 42% reporting it as mild and 41% as moderate. Headaches reported by 44.28% (CI95%:41.74-46.80), with 51% claiming to be mild and 34% as moderate. Females had significantly (p = &lt;0.01 respectively) more pain (OR:1.90), redness (OR:2.49), swelling at the injection site (OR:1.33), fever (OR:1.74), chills (OR:2.32), fatigue (OR:2.43), muscle (OR:1.54) and joint pains (OR:2.01), headache (OR:2.07) and vomiting (OR:3.43) when adjusted for age and HCW role. Younger individuals (18-34 years) reported higher SE rates than older adults. Localised SE was reported following both vaccine doses, unlike systemic SE that was mostly reported following second doses. Conclusions Females and young adults appeared to be more susceptible to SE among this study's cohort, however the nature of these SE was mostly mild or moderate. This is encouraging and should allay vaccine apprehension/hesitancy. Key messages Vaccination benefits outweigh the minor side effects experienced. Caring physicians should be notified of the female higher susceptibility to side effects. Vaccination should be encouraged among all eligible population.

scholarly journals Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Optimal Number ◽  
Significant Difference ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p &lt; 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p &lt; 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p &lt; 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p &lt; 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

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